Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5370](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5370) → KHT — Fraction V, Antigen, Antiserum, Control

# KHT · Fraction V, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5370 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KHT

## Overview

- **Product Code:** KHT
- **Device Name:** Fraction V, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5370](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5370)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A Cohn fraction V immunological test system is a device that consists of or measures that fraction of plasma containing predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be depressed, e.g., nephrosis (disease of the kidney), proteinuria (protein in the urine), gastroenteropathy (disease of the stomach and small intestine), rheumatoid arthritis, and viral hepatitis.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K822516](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KHT/K822516.md) | VIVONEX MASS GASTRASTOMY TUBE | Norwich Eaton Pharmaceuticals, Inc. | Sep 7, 1982 | SESE |

## Top Applicants

- Norwich Eaton Pharmaceuticals, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KHT](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KHT)

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